No More Over-the-Counter Cough Syrups in India: What Changed?
- Jun 16
- 2 min read
By The Slate Bureau
New Delhi, June 16: In a significant regulatory move which follows busting of a racket in Uttar Pradesh involving smuggling of cough syrup which led to several arrests last year, the Centre on Tuesday removed the word "syrup" from Schedule K of the Drugs Rules, 1945, effectively ending an exemption that had allowed certain syrups, including cough formulations, to be sold in villages without a doctor's prescription.
The exemption was originally intended to ensure access to basic medicines in remote and underserved areas where licensed pharmacies were not readily available. With the latest amendment, cough syrups can now be sold and dispensed only through duly licensed pharmacies in accordance with the provisions of the Drugs and Cosmetics Act, 1940, and the rules framed under it.
"Consequently, the sale and dispensing of cough syrups in smaller villages will now be required to take place only through duly licensed pharmacies," the Health Ministry said in a statement.
In 2025, investigators uncovered an illegal drug racket involving smuggling of codeine-based cough syrup following some arrests in Uttar Pradesh. It was discovered that it was a scam worth hundreds of crore with the syrup being sold illegally in rural areas of the country and being smuggled to some neighbouring countries.
A draft notification for regulating sale of syrups was issued in December last year, inviting objections and suggestions from stakeholders. Now the change has been notified through the Drugs (Fifth Amendment) Rules, 2026, published in the Official Gazette.
According to the ministry, the amendment is aimed at strengthening regulatory oversight of syrup-based formulations and aligning the exemption framework with current public health and safety requirements.
"The measure is expected to promote responsible distribution and sale of cough syrups while ensuring greater compliance with regulatory standards across the country," the ministry said.
Manufacturers, distributors and retailers dealing with cough syrups have been advised to ensure strict adherence to all applicable licensing and regulatory requirements under the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945.
The decision comes amid heightened scrutiny of cough syrups and other liquid oral medicines following reports of contamination-linked child deaths in several countries in recent years.
The amendment is expected to improve traceability, accountability and regulatory supervision of syrup-based medicines by ensuring that their manufacture, distribution and sale take place through licensed and monitored channels, supported by stricter quality-control standards.
